ClearanceBrief
Panels › Clinical Chemistry › Product code NBW · Class 2

System, Test, Blood Glucose, Over The Counter

Regulation 862.1345

5510(k)s in 12 months (513 all time)
4recalls in 12 months (137 all time)
100recalls that name a 510(k)
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Top companies in NBW

Company510(k)sRecalls
Taidoc Technology Corporation650
Abbott Diabetes Care1922
Lifescan, Inc.1317
Roche Diagnostics198
I-Sens, Inc.220
Apex BioTechnology Corp.180
Bionime Corporation180
Roche Diabetes Care413
Nova Biomedical Corp.610
EPS Bio Technology Corp.150
Decided510(k)Device and applicantCode
Mar 12, 2010K093930DIDGET WORLD REPORTS
Bayer Healthcare, LLC
NBW
Mar 2, 2010K093764SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM
Biotest Medical Corp., TW
NBW
Mar 2, 2010K092902U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE MONITORING SYSTEM, TD-4256 BLOOD GLUC
Taidoc Technology Corporation, TW
NBW
Feb 25, 2010K093592ADVOCATE REDI-COD DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223
Taidoc Technology Corporation, TW
NBW
Feb 24, 2010K093475BASESENS BLOOD GLUCOSE MONITORING SYSTEM
Hygeia, Inc.
NBW
Feb 24, 2010K092894EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM
Eps Bio Technology Corp., TW
NBW
Feb 19, 2010K093789INTOUCH DIABETES
Symcare Personalized Health Solutions, Inc.
NBW
Feb 19, 2010K093712FORA G71A BLOOD GLUCOSE MONITORING SYSTEM, TD-4274 BLOOD GLUCOSE MONITORING SYSTEM
Taidoc Technology Corporation, TW
NBW
Feb 18, 2010K093635MODELS FORA V30 AND TD-4242 BLOOD GLUCOSE MONITORING SYSTEMS
Taidoc Technology Corporation, TW
NBW
Feb 5, 2010K093005FORA G72 BLODO GLUCOSE MONITORING SYSTEM/TD-4264 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4264
Taidoc Technology Corporation, TW
NBW
Feb 4, 2010K090609OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM
Ok Biotech Co., Ltd., TW
NBW
Jan 19, 2010K091765EBCARRYON BLOOD GLUCOSE MONITORING SYSTEM
Visgeneer, Inc., TW
NBW
Jan 15, 2010K091547NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS
Nova Biomedical Corp.
NBW
Dec 24, 2009K093035FORA V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244
Taidoc Technology Corporation, TW
NBW
Dec 10, 2009K092099NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4251, TD-4252, TD-4253 AND TD-4254
Taidoc Technology Corporation, TW
NBW
Dec 8, 2009K082683SD CHECK GOLD
Standard Diagnostics, Inc.
NBW
Dec 4, 2009K090628DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080
Bayer Healthcare, LLC
NBW
Dec 1, 2009K090405LIPIDPRO SYSTEM
Infopia Co, Ltd.
NBW
Nov 19, 2009K083273MICRODOT XTRA
Cambridge Sensors Limited, GB
NBW
Nov 17, 2009K091157GLUCO LAB AUTO CODING, MODEL IGM-0022
Infopia Co, Ltd.
NBW
Nov 16, 2009K091815SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268
Biotest Medical Corp.
NBW
Oct 21, 2009K092887EASYPLUS MINI MASTERDRIVER SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS09009
Eps Bio Technology Corp., TW
NBW
Oct 9, 2009K090653POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM
Arkray Factory USA, Inc.
NBW
Oct 2, 2009K090712EOCENE SYSTEM
Infopia Co, Ltd.
NBW
Sep 18, 2009K091898BLOOD GLUCOSE MONITORING SYSTEM, MODEL FORA G90/TD-4234
Taidoc Technology Corporation, TW
NBW
Aug 26, 2009K091820CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM
Bayer Healthcare
NBW
Aug 18, 2009K091481EASYPLUS MINI R13N SELF MONITORING BLOOD GLUCOSE SYSTEM
Eps Bio Technology Corp., TW
NBW
Aug 14, 2009K090332ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001
Arkray Factory USA, Inc.
NBW
Jul 31, 2009K091229GLUCOMANAGER DATA MANAGEMENT SOFTWARE
Eps Bio Technology Corp., TW
NBW
Jul 17, 2009K091296POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09
Polymap Wireless
NBW
Jul 14, 2009K090389AP-1000 BLOOD GLUCOSE MONITORING SYSTEM
Bestgen Biotech Corp., TW
NBW
Jul 13, 2009K090188U-RIGHT TD-4227 NO CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4222
Taidoc Technology Corporation, TW
NBW
Jun 23, 2009K090404FORE V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244, FOREA V12 BLODO GLUCOSE MONITORING SYSTEM, MODEL TD-4247
Taidoc Technology Corporation, TW
NBW
Jun 4, 2009K090629EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMS
Tyson Bioresearch, Inc., TW
NBW
May 12, 2009K090187FORA G30 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241
Taidoc Technology Corporation, TW
NBW
May 1, 2009K083628GLUCODR AUTO SYSTEM
All Medicus Co., Ltd., KR
NBW
Apr 24, 2009K090185CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM; ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM
Taidoc Technology Corporation, TW
NBW
Apr 8, 2009K090057ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM
Acon Laboratories Co.
NBW
Mar 27, 2009K090495TRUEBALANCE BLOOD GLUCOSE SYSTEM
Home Diagnostics, Inc.
NBW
Mar 26, 2009K090536FORA V12 NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4247
Taidoc Technology Corporation, TW
NBW
Mar 24, 2009K062187BETACHEK GLUCOSE TEST
National Diagnostic Products, AU
NBW
Mar 13, 2009K083263SYMCARE DIABETES MANAGEMENT PROGRAM
Symcare Personalized Health Solutions, Inc.
NBW
Feb 27, 2009K082328GLUCODR PLUS SYSTEM, MODEL AGM-3000
All Medicus Co., Ltd., KR
NBW
Feb 20, 2009K082201G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A
U. S. Diagnostics, Inc.
NBW
Feb 20, 2009K080853DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM
Genexel-Sein, Inc.
NBW
Feb 10, 2009K083468CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR)
I-Sens, Inc., KR
NBW
Feb 3, 2009K083265JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381
Agamatrix, Inc.
NBW
Jan 23, 2009K081796EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEM
Eps Bio Technology Corp., TW
NBW
Jan 16, 2009K083099EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008
Eps Bio Technology Corp., TW
NBW
Jan 16, 2009K082521EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM
Card Guard Scientific Survival , Ltd., IL
NBW

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